The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Hdl Cholesterol Reagent.
| Device ID | K891117 |
| 510k Number | K891117 |
| Device Name: | HDL CHOLESTEROL REAGENT |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | William F Walters |
| Correspondent | William F Walters POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-02 |
| Decision Date | 1989-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727011459 | K891117 | 000 |
| 00811727011435 | K891117 | 000 |